Health Authority (HA) Communications
Relationships between the pharmaceutical industry and regulatory agencies across the globe often get complicated, and one main reason that leads to this complicated state is ‘Communication’. How well and transparently a firm communicates with the regulators often leads to the state of affairs.
Communicating with Health Authorities
Despite the agency’s clarity around applicable regulations and their oversight role through the publication of guidance documents, firms still need ‘Increased transparency’ in their communications.
This, in turn, is driving change in how regulatory agencies perceive the ‘Culture’ at the firms. We have decades of experience hosting, responding to, defending, and meeting regulators.
We can guide you at every step of the agency communication process, from Pre-Inspection (review and advice on the FDA questionnaire for announced Inspections, preparing SMEs and staff for unannounced Inspections, FDAR-driven communications, how to communicate during inspection, after inspection and how to prepare for regulatory meetings).
We have helped firms for successful outcomes many times.